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8110 Gatehouse Road, Falls Church, VA 22042

Prospective, Multicenter, Single Arm Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System with Continued Access EVAS I Study with Continued Access

General Information

Age Group

Adult

Status

Active

Protocol Number

CP-0008

Background Information

Primary objective is to study the safety and effectiveness of the Nellix System for Endovascular Abdominal Aortic Aneurysm (AAA) repair. Procedures will be performed per the instructions for use, and per institutional protocols and standard of care for endovascular aneurysm repair. As such, this study will evaluate the safety and effectiveness of the device system among a wide range of physicians and in consecutively enrolled subjects to assess outcomes generalizability.

Offered At

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Homoyoun Hashemi, MD

Eligibility Information

  1. Male or female at least 18 years old;
  2. Informed consent understood and signed;
  3. Patient agrees to all follow-up visits;
  4. Have an infrarenal abdominal aortic aneurysm (AAA) with maximum sac diameter ≥5.0cm, or ≥ 4.5 cm which has increased by ≥0.5cm within the last 6 months., or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment.
  5. Anatomic eligibility for the Nellix System per the instructions for use:
    1. Adequate iliac/femoral access compatible with the required delivery systems (diameter ?6 mm);
    2. Aneurysm blood lumen diameter ≤60mm;
    3. Proximal non-aneurysmal aortic neck: length ?10mm; lumen diameter 18 to 32mm; angle ?60° to the aneurysm sac;
    4. Most caudal renal artery to each hypogastric artery length ?100mm;
    5. Common iliac artery lumen diameter between 9 and 35mm;
    6. Ability to preserve at least one hypogastric artery.

Ineligibility Information

  1. Life expectancy <2 years;
  2. Psychiatric or other condition that may interfere with the study;
  3. Participating in another clinical study
  4. Known allergy to device any device component;
  5. Coagulopathy or uncontrolled bleeding disorder;
  6. Ruptured, leaking or mycotic aneurysm;
  7. Serum creatinine level >2.0mg/dL;
  8. CVA or MI within three months of enrollment/treatment;
  9. Aneurysmal disease of the descending thoracic aorta;
  10. Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) of the infrarenal non-aneurysmal neck (>5mm thickness over >50% circumference);
  11. Connective tissue diseases (e.g., Marfan Syndrome)
  12. Unsuitable vascular anatomy;
  13. Pregnant (females of childbearing potential only).